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Topical Area: Vitamins and Minerals

Vitamins and Minerals (Poster Session)

(P11-006-23) Vitamin B12 Status in Infancy and the Effect of a Vitamin B12 Injection in Infants With Subclinical Vitamin B12 Deficiency: A Register-Based Randomized Controlled Trial

Saturday, July 22, 2023
12:00 PM – 1:00 PM ET
Location: Poster Board 229
Disclosure(s):
Maria O'Keeffe, M.Sc: No relevant financial relationship(s) with ineligible companies to disclose.
Adrian McCann, PhD: No relevant financial relationship(s) with ineligible companies to disclose.


Objectives: The aim of this study is twofold; 1) to describe vitamin B12 status and the status of other micronutrients in Norwegian infants, and 2) in a randomized controlled trial (RCT), investigate the effect of vitamin B12 supplementation on neurodevelopment in infants with subclinical vitamin B12 deficiency.

Methods: Infant blood samples, collected at public healthcare clinics, are analyzed for plasma cobalamin levels. Infants with plasma cobalamin < 148 pmol/L are immediately treated with hydroxocobalamin. Remaining infants (cobalamin ≥148 pmol/L) are randomly assigned (in a 1:1 ratio) to either a screening or a control group. In the screening group, baseline samples are immediately analyzed for total homocysteine (tHcy), while in the control group, the baseline samples will be analyzed after 12 months. Screening group infants with plasma tHcy >6.5µmol/L, are given an intramuscular injection of hydroxocobalamin (400 µg). The primary outcomes are cognitive, language and motor development assessed using the Bayley Scales of Infant and Toddler Development at 12 months of age.

Results: The study is ongoing. By February 20th 2023, the study has included and drawn blood from 181 participants where 6% has been treated for vitamin B12 deficiency (plasma cobalamin < 148 pmol/L). A total of 77 infants has been included in the screening group, where 64% has been treated for subclinical vitamin B12 deficiency (plasma tHcy >6.5µmol/L).

Conclusions: Subclinical vitamin B12 deficiency are common among Norwegian infants. The study is still ongoing and the effects of supplementation with high dose hydroxocobalamin in early infancy on growth and neurodevelopment will be revealed in the future.

Funding Sources: This work was supported by South-Eastern Norway Regional Health Authority, Innlandet Hospital Trust, and the Norwegian Regional research funds.